Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Australasian Medical & Scientific Ltd - Stylage M - Dermal tissue reconstructive material, microbe-derived
ARTG entry for
Medical Device Included Class III
Australasian Medical & Scientific Ltd
PO Box 5197,WEST CHATSWOOD, NSW, 1515
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
252 Rue Douglas Engelbart Archamps
, Archamps, 74160
1. Stylage M - Dermal tissue reconstructive material, microbe-derived
Single Device Product
59131 Dermal tissue reconstructive material, microbe-derived
Sterile, cross-linked hyaluronic acid gel with physiological pH and osmolarity. When injected, the device
generates volume by filling in the treatment area and is reabsorbed over time. The device is packed in a
1mL pre-filled syringe.
Stylage® M is an injectable hyaluronic acid gel, intended to fill in facial skin depression (i.e. treatment of
nasolabial folds) by injection into the dermis, by a skilled legally qualified practitioner trained in techniques
for injecting implants.
Nil variant (as 1 device) Not Applicable
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 24.11.2017 at 06:47:31 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information